For decades, complementary and alternative medicines (CAMs) have been sold in South Africa without government regulation.

While new legislation promises greater protection to the millions of consumers who use these products – from homeopathic remedies to Chinese herbal preparations – manufacturers and distributors complain that it will have a devastating impact on their multi-billion rand industry.

Critics in the medical profession have long pointed out that many of the therapeutic claims made by certain CAMs have never been formally tested and that some are known to contain toxic ingredients like arsenic, lead and mercury.

At the end of last year, the Minister of Health published amendments to the Medicines and Related Substances Act, providing for the regulation of CAMs by the Medicines Control Council (MCC).

According to the MCC's Dr Joey Gouws, the motivation for the regulations was a need to assure the safety, quality and efficacy of CAMs in line with the council's mandate to protect the public: “The period after 1994 saw a significant influx of CAMs into the country, necessitating an audit to survey the local market. Growing concern over the impact of these products as well as a number of deaths attributed to contaminated CAMs led to the establishment of a legal framework to regulate them”.

• All other CAMs that do not fall in this new category are included in the existing category A, together with conventional medicines.

• All existing and new CAMs must be submitted to the MCC for safety, quality and efficacy assessment and registration.

• All category D medicines must be appropriately labelled and any product not registered with the MCC must carry a label declaring: “This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease”.

• All CAM products that contain banned substances (e.g. apiol or kava kava) which are potentially dangerous to public health must be withdrawn

• All CAMs manufacturers and wholesalers must be licensed.

Industry concerns

The new regulations have come in for scathing criticism from the CAMs industry and have been described as “vague and confusing”, “totally inappropriate”, “unreasonable, unworkable and unnecessarily onerous”, “draconian, misleading and insulting”, and “unconstitutional, illegal and discriminatory”, prompting the Health Products Association (HPA), an affiliation of 114 companies, to sue the Minister of Health.

One particular concern relates to those CAMs which contain substances that are listed in schedules 1 or higher of the Medicines and Related Substances Act. Under the law, all medicines are classified according to their potential health risk and assigned to schedules numbered 0 (low risk) to 7 (high risk).

According to the new regulations, any CAMs that fall into schedules 1 or higher must be withdrawn from the market immediately (until they are properly registered with the MCC), potentially removing 60 to 85% of all current CAMs from the shelves.

Popular products affected by this include milk thistle, a herbal product with liver protecting properties, melatonin, which is used to treat sleep problems and other conditions, bitter orange and red yeast rice.

Other concerns voiced by the industry include claims that stakeholders were not adequately consulted, that their recommendations were not incorporated in the regulations, and that the public was not given sufficient time to comment.

The impact

“We see the regulations as a major threat to this industry and extremely damaging to our economy,” says HPA chair Norman Fels, who explains that the local CAMs industry has an estimated annual turnover of R7 billion and that the new regulations could result in an overall loss to the economy of R20 billion.

The legislation is already affecting large manufacturers such as Adcock Ingram and retailers like Clicks. The significant costs involved in the registration process are expected to be particularly draining on smaller companies.

Consumers may find their favourite CAMs to be more expensive, harder to obtain or even entirely removed from the market.

While Fels acknowledges that “there are some cowboys out there, selling dangerous products”, he emphasises that the HPA has been in favour of legislation guaranteeing safety, efficacy and quality for more than 25 years.

He believes, however, that it is unfair to treat CAMs in the same way as conventional pharmaceuticals.

“It's a constitutional right to choose your health modality, and just because it doesn't fit into an orthodox paradigm, this is no excuse to deprive people of that right,” he says. “The greater part of our population uses complementary medicines. You can't just legislate them out of existence”.

Dr Gouws disagrees: “Products that qualify as true CAMs fall into category D and are subject to less stringent requirements for registration as is appropriate for such medicines.

There are, however, a number of products that are being marketed as CAMs which are not really complementary or alternative, but are presented to the public as directly competing alternatives to conventional medicines.

As such, they need to be treated as category A medicines subject to more rigorous standards of safety, quality and efficacy”.

What about African traditional medicines?

Contrary to some reports, the new regulations do not affect the African traditional medicines used regularly by millions of South African, which are dealt with by a separate committee of the MCC. They may become subject to their own legislative rules in future.

Also excluded are a number of products that may be sold under the provisions of the Foodstuffs, Cosmetics and Disinfectants Act, such as vitamins, electrolytes and minerals, as well as aromatherapy preparations which make no therapeutic claims.

What are your thoughts? Should CAMs be regulated and, if so, in the same way Western/allopathic meds are? Let us know in the comments below. You can also tweet any questions or comments at the author, Andreas Wilson-Spath

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